Locally Advanced Breast CancerNEOZOL_FUNCT04899713
NEOZOL_Follow-up Study
An observational study of Locally Advanced Breast Cancer, run by Hospices Civils de Lyon at 11 sites in France.
Trial summary
Breast cancer is the most common cancer in women and is the leading cause of death from cancer in France. The main types of treatment used to treat breast cancer are surgery, chemotherapy, radiotherapy, hormone therapy and targeted therapies. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Locally Advanced Breast Cancer
- What is being tested?
- Survival survey
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 11 sitesFrance
- Study dates
- May 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of 50 patients with locally advanced breast cancer (TNM IIa or IIb or IIIa, tumor > 2 cm, ductal or lobular histology), who benefited from neoadjuvant chemotherapy associated ( n = 26) or not (n = 24) with the zoledronic acid, and having participated in the NEOZOL study (NCT01367288)
Who may be able to join
- Woman who signed a written consent, included and randomised in the main analysis of the NEOZOL study
Who cannot join
- Patient's opposition to the use of her data in this study
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Centre hospitalier de Bourg en Bresse, Hôpital Fleyriat, Service d'Onco-Hématologie et de Gynécologie Obstétrique
Bourg-en-Bresse, 01012
LAMBERT, MD, 474 454 647 ext. +33, jrlambert@ch-bourg01.fr
ORFEUVRE, MD, 474 454 647 ext. +33, horfeuvre@ch-bourg01.fr
Hôpital Femme Mère Enfant, Groupement Hospitalier EST, Service de Gynécologie Clinique
Bron, 69677
LE BAIL-CARVAL, MD, 427 855 353 ext. +33, muriel.doret-dion@chu-lyon.fr
Centre de Lutte Contre le Cancer - Institut Jean Perrin, Service de Médecine Oncologique
Clermont-Ferrand, 63011
MOURET-REYNIER, MD, 473 278 080 ext. +33, marie-ange.mouret-reynier@cjp.fr
Centre Hospitalier Alpes Léman, Service de Gynécologie
Contamine-sur-Arve, 74130
GIRARD, MD, 450 822 000 ext. +33, sgirard@ch-alpes-leman.fr
Centre Hospitalier Universitaire de Limoges, Hôpital Dupuytren 1, Service d'Oncologie Médicale,
Limoges, 87022
TUBANIA-MATHIEU, MD, 555 055 555 ext. +33, nicole.tubiana-mathieu@chu-limoges.fr
Centre Léon Bérard, Département de Cancérologie Médicale
Lyon, 69373
RAY-COQUARD, MD, 478 782 888 ext. +33, isabelle.ray-coquard@lyon.unicancer.fr
Hôpital Européen, Service d'Oncologie
Marseille, 13003
DALIVOUST, MD, 491 833 838 ext. +33, philippedalivoust@gmail.com
Centre Hospitalier Universitaire de Montpellier - Hôpital St Eloi
Montpellier, 34295
TOPART, MD, 467 330 176 ext. +33, d-topart@chu-montpellier.fr
pl-giacalone@chu-montpellier.fr
Centre Hospitalier Universitaire de Poitiers, Hôpital la Milétrie
Poitiers, 86021
FRITEL, MD, 549 444 444 ext. +33, xavier.fritel@chu-poitiers.fr
RABAN, MD, 549 444 444 ext. +33, nadia.raban@chu-poitiers.fr
Institut de Cancérologie de la Loire Lucien Neuwirth
Saint-Priest-en-Jarez, 42270
CHAULEUR, MD, 477 917 000 ext. +33
JACQUIN, MD, 477 917 000 ext. +33, jean-philippe.jacquin@icloire.fr
Centre Hospitalier de Thonon Hôpitaux du Léman, site Georges Pianta Service de Gynécologie Obstétrique
Thonon-les-Bains, 74203
DELPIANO, MD, 450 832 000 ext. +33, f-delpiano@ch-hopitauxduleman.fr
About this study
Official title: Long-term Survival of Locally Advanced Breast Cancer Patients Treated With Neoadjuvant Chemotherapy With or Without Zoledronic Acid (ZOMETA®)
Breast cancer is the most common cancer in women and is the leading cause of death from cancer in France.
The main types of treatment used to treat breast cancer are surgery, chemotherapy, radiotherapy, hormone therapy and targeted therapies. In locally advanced breast cancer, a neo-adjuvant chemotherapy treatment is currently recommended as it may provide a sufficient tumour response to allow for conservative breast treatment.
Read more
Zoledronic acid (ZOL) is an N-biphosphonate used in the prevention of bone complications and in the treatment of hypercalcaemia In vitro and in vivo studies have shown an effect of ZOL on tumour and endothelial cells, supporting an anti-tumour activity of N-biphosphonates.
Between April 2010 and October 2013, 50 patients with locally advanced breast cancer were randomized in the NEOZOL study to receive neoadjuvant chemotherapy with (n=26) or without (n=24) zoledronic acid (ClinicalTrials.gov Identifier: NCT01367288). The primary objective of this study was to evaluate the effect of the addition of ZOMETA® to neoadjuvant chemotherapy on the change in serum VEGF concentration before and after neoadjuvant treatment (i.e. at the time of surgery).
Assessment of long-term survival was not planned in the NEOZOL study protocol. The objective of NEOZOL_FU study is to evaluate the survival of patients included in the NEOZOL study, 7 years after inclusion of the last patient.
This study will provide essential data on the long-term survival and risk of relapse of patients with locally advanced breast cancer who have received neo-adjuvant chemotherapy with or without zoledronic acid (ZOMETA®).
- Conditions
- Locally Advanced Breast Cancer
- Being tested
- Survival survey
- Keywords
- Breast cancer, Zometa®, Survival survey, Neoadjuvant chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survival surveyOther
To assess the effect of adding ZOMETA® to neoadjuvant chemotherapy on event-free survival.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (neo-adjuvant chemotherapy combined with ZOMETA®) (zoledronic acid) | Patients treated every 3 weeks (+/- 2 days ) for 8 cycles in total. The 4 first cycles : zoledronic acid 4 mg (in a 15 min. infusion) + doxorubicin (60 mg/m²) + cyclophosphamide (600 mg/m²). The 4 last cycles with zoledronic acid 4 mg (in a 15 min. infusion) + docetaxel (100 mg/m²) Receives: Other: Survival survey | |
| Control group (neo-adjuvant chemotherapy alone) | Patients treated every 3 weeks (+/- 2 days) for 8 cycles in total. The 4 first cycles : doxorubicin (60 mg/m²) combined with cyclophosphamide (600 mg/m²). The 4 last cycles with docetaxel (100 mg/m²) Receives: Other: Survival survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
Event-free survival is defined as the time between the date of randomization and the date of the 1st event among: 1st documented locoregional or metastatic infiltrating relapse (not including in situ relapses) or death from whatever cause.
Measured: 31/12/2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study startMay 2021 (estimated)
- Primary completion30 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899713
- Sponsor's protocol ID
- 69HCL21_0552
- Acronym
- NEOZOL_FU
- Status last verified
- May 2021
- First submitted
- 21 May 2021
- Last updated
- 24 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Survival of Locally Advanced Breast Cancer Patients Treated With Neoadjuvant Chemotherapy With or Without Zoledronic Acid (ZOMETA®)
- ClinicalTrials.gov ID
- NCT04899713
- Acronym / sponsor ID
- NEOZOL_FU / 69HCL21_0552
- Conditions
- Locally Advanced Breast Cancer
- Keywords
- Breast cancer, Zometa®, Survival survey, Neoadjuvant chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast cancer is the most common cancer in women and is the leading cause of death from cancer in France.
The main types of treatment used to treat breast cancer are surgery, chemotherapy, radiotherapy, hormone therapy and targeted therapies. In locally advanced breast cancer, a neo-adjuvant chemotherapy treatment is currently recommended as it may provide a sufficient tumour response to allow for conservative breast treatment.
Zoledronic acid (ZOL) is an N-biphosphonate used in the prevention of bone complications and in the treatment of hypercalcaemia In vitro and in vivo studies have shown an effect of ZOL on tumour and endothelial cells, supporting an anti-tumour activity of N-biphosphonates.
Between April 2010 and October 2013, 50 patients with locally advanced breast cancer were randomized in the NEOZOL study to receive neoadjuvant chemotherapy with (n=26) or without (n=24) zoledronic acid (ClinicalTrials.gov Identifier: NCT01367288). The primary objective of this study was to evaluate the effect of the addition of ZOMETA® to neoadjuvant chemotherapy on the change in serum VEGF concentration before and after neoadjuvant treatment (i.e. at the time of surgery).
Assessment of long-term survival was not planned in the NEOZOL study protocol. The objective of NEOZOL_FU study is to evaluate the survival of patients included in the NEOZOL study, 7 years after inclusion of the last patient.
This study will provide essential data on the long-term survival and risk of relapse of patients with locally advanced breast cancer who have received neo-adjuvant chemotherapy with or without zoledronic acid (ZOMETA®).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group (neo-adjuvant chemotherapy combined with ZOMETA®) (zoledronic acid) | – | Other: Survival surveyPatients treated every 3 weeks (+/- 2 days ) for 8 cycles in total. The 4 first cycles : zoledronic acid 4 mg (in a 15 min. infusion) + doxorubicin (60 mg/m²) + cyclophosphamide (600 mg/m²). The 4 last cycles with zoledronic acid 4 mg (in a 15 min. infusion) + docetaxel (100 mg/m²) |
| Control group (neo-adjuvant chemotherapy alone) | – | Other: Survival surveyPatients treated every 3 weeks (+/- 2 days) for 8 cycles in total. The 4 first cycles : doxorubicin (60 mg/m²) combined with cyclophosphamide (600 mg/m²). The 4 last cycles with docetaxel (100 mg/m²) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of 50 patients with locally advanced breast cancer (TNM IIa or IIb or IIIa, tumor > 2 cm, ductal or lobular histology), who benefited from neoadjuvant chemotherapy associated ( n = 26) or not (n = 24) with the zoledronic acid, and having participated in the NEOZOL study (NCT01367288)
Key inclusion criteria (1 listed)
- Woman who signed a written consent, included and randomised in the main analysis of the NEOZOL study
Key exclusion criteria (1 listed)
- Patient's opposition to the use of her data in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survival surveyTo assess the effect of adding ZOMETA® to neoadjuvant chemotherapy on event-free survival. | Other | Control group (neo-adjuvant chemotherapy alone), Experimental group (neo-adjuvant chemotherapy combined with ZOMETA®) (zoledronic acid) |
Primary outcome
Event-free survival
Time frame: 31/12/2019
Event-free survival is defined as the time between the date of randomization and the date of the 1st event among: 1st documented locoregional or metastatic infiltrating relapse (not including in situ relapses) or death from whatever cause.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Breast Cancer, run by Hospices Civils de Lyon at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MATHEVET, MD (795 567 520 ext. +41, Patrice.Mathevet@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (time frame: 31/12/2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.